On October 26, 2021 FUJIFILM Diosynth Biotechnologies (FDB) and Istari Oncology reported that they have entered into an agreement for the manufacturing of Istari Oncology’s viral immunotherapy, PVSRIPO, currently being investigated for the treatment of solid tumors (Press release, Istari Oncology, OCT 26, 2021, View Source [SID1234593959]).
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FUJIFILM Diosynth Biotechnologies is a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies. Istari Oncology is a clinical-stage biotechnology company focused on novel immunotherapies for the treatment of solid tumors.
Istari Oncology selected FUJIFILM Diosynth Biotechnologies as its partner for drug substance manufacturing and filling of its recombinant viral immunotherapy PVSRIPO, which is based on the Sabin Type 1 poliovirus vaccine. Drug substance manufacturing and filling will be carried out in FUJIFILM Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, Texas. Manufacturing at FDB will support Istari Oncology’s three ongoing clinical trials being conducted across six potential indications including glioblastoma, melanoma, bladder cancer, and head and neck cancer, as well as studies planned in the future.
"Our decision to collaborate with FUJIFILM Diosynth Biotechnologies on the manufacturing of PVSRIPO has already paid off in multiple ways," said Jamie Iudica, chief manufacturing officer, Istari Oncology. "Despite manufacturing constraints other biotechnology companies have experienced due to the pandemic, FDB has demonstrated a patient focused mindset and has continued to support Istari by working tirelessly to identify and mitigate supply risks for our clinical trials."
"We are proud of our role as a manufacturing partner to Istari Oncology. Supporting the supply of potential therapies to oncology patients is at the core of what we do every day," said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. "Our entire FDB team is honored to be playing a critical part of the clinical journey of PVSRIPO."
About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO targets cells using the poliovirus receptor CD155, which is widely expressed on both the malignant cells of most solid tumors and key antigen-presenting cells (APCs) within the tumor microenvironment. PVSRIPO targets tumors using three key mechanisms: 1) engagement and activation of APCs, leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of poliovirus vaccine-specific T cells. PVSRIPO has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.